The aim of this study is to investigate the effect of a specific rehabilitation program with an oral device used in stroke patients with persistent oral-and pharyngeal dysphagia.
This study aims to investigate the effect of oral neuromuscular training in stroke patients with persistent oral- and pharyngeal dysphagia 12 (±3) weeks after stroke onset. Interventional study with PROBE-design (prospective randomized open-label blinded evaluator). Consecutive patients with first-ever stroke without previously known dysphagia with persistent dysphagia (DOSS\<6) at 3 months (12±3 weeks) post-stroke onset. Patients are eligible to participate if they are admitted to one of the following seven hospitals/centers in Sweden: Umeå University Hospital, Danderyds Hospital, Södersjukhuset, Skaraborg Hospital (Skövde), Helsingborg Hospital, Halland Hospital, Kungälv Hospital, Kalix Hospital, Skellefteå Hospital, and Ellenbogen in Malmö. Further centers will be recruited. Exclusion criteria: Unable/unwilling to give informed consent or to cooperate. Randomization will be made web-based 1:1 by use of the developed REDCap system with stratification for center and aspiration (yes/no). In total, 336 stroke patients (168 intervention group; 168 control group) with persistent dysphagia 12(±3) weeks after stroke onset will be included in the present study. The intervention group will be offered to undergo oral neuromuscular training alongside routine care with compensatory training for 3 months. The control group will only be offered routine care with compensatory training for 3 months. The participants' status regarding swallowing function, nutritional status, quality of life related to swallowing, pneumonia, functional status including lip force, and death will be assessed before and after the completed intervention period, and 6 months post-intervention. The primary endpoint will be analyzed using an ordinal regression (proportional odds) model, adjusting for baseline DOSS as well as for the stratifying variables center and aspiration. The investigators hypothesize that swallowing intervention with oral neuromuscular training is more effective than routine care rehabilitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
The oral device is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial and pharyngeal muscles.
University Hospital of Umeå
Umeå, Sweden
RECRUITINGSwallowing Function
Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES)
Time frame: At start compared with at end of treatment (after 3 months)
Swallowing function
Change in swallowing function measured by the Dysphagia Outcome Severity Scale (DOSS) using Fiberoptic endoscopic evaluation of swallowing (FEES)
Time frame: At start and 6 months post-intervention
Lip-force (LF)
Change in lip-force measured in newtons (N) with the Lip Force Meter LF100.
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Swallowing Quality of Life Questionnaire (SWAL-QOL)
Change in quality of life related to swallowing measured by the SWAL-QOL questionnaire.
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Nutritional status
Change in nutritional status measured with the Mini Nutritional Assessment (MNA).
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Activity of daily living (ADL)
Change in activity of daily living (ADL) measured by Barthels Index (BI).
Time frame: At start, at end of treatment (after 3 months) and 12-18 months post-intervention
Global disability
Change in global disability measured with modified Rankin Scale (mRS)
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Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Aspiration-pneumonia
Change in rate of aspiration-pneumonia based on the modified criteria by Centers for Disease Control and Prevention (CDC) for stroke-associated pneumonia
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention
Death
Change in rate of death
Time frame: At start, at end of treatment (after 3 months) and 6 months post-intervention